Alessi-Severini Silvia, Honcharik Patricia L, Simpson Karleen D, Eleff Michael K, Collins David M
Faculty of Pharmacy, University of Manitoba, Winnipeg, Manitoba, Canada.
J Clin Psychiatry. 2006 Jul;67(7):1047-54. doi: 10.4088/jcp.v67n0706.
To report the findings of a switch from brand-name to generic clozapine in a Canadian outpatient population.
The medical records of 58 outpatients diagnosed with schizophrenia and other psychotic disorders and stabilized on brand-name clozapine therapy were reviewed retrospectively. Patients were switched from brand-name to generic clozapine on their next dispensing supply after September 29, 2003. Data regarding clozapine dose regimens, physicians' visits, hospitalizations, and adverse events were collected from the patients' charts for the 6 months preceding and the 6 months after the switch from brand-name to generic clozapine. Relevant measurement changes in those data associated with the switch are evaluated.
No significant changes in dose, number of physician's visits, or hospitalization rates were observed as a consequence of the switch from brand-name to generic clozapine. In addition, there were no reported increases in the frequency of the most common adverse events, including decreases in white blood cell counts. None of the patients received a "nonrechallengeable" status, and no discontinuation of clozapine therapy occurred for any reason (toxicity or treatment failure) in the 6 months after the formulation switch.
In the current outpatient population, retrospective evaluation of the conversion from brand-name clozapine to the first generic alternative available on the Canadian market did not reveal any significant treatment changes.
报告加拿大门诊患者从品牌名氯氮平转换为通用名氯氮平的研究结果。
回顾性分析58例诊断为精神分裂症及其他精神障碍且使用品牌名氯氮平治疗病情稳定的门诊患者的病历。患者于2003年9月29日之后的下次配药时从品牌名氯氮平转换为通用名氯氮平。收集患者从品牌名氯氮平转换为通用名氯氮平之前6个月和之后6个月的病历中有关氯氮平剂量方案、医生问诊、住院情况及不良事件的数据。评估与转换相关的这些数据的相关测量变化。
从品牌名氯氮平转换为通用名氯氮平后，未观察到剂量、医生问诊次数或住院率有显著变化。此外，未报告最常见不良事件的发生率增加，包括白细胞计数减少。在剂型转换后的6个月内，没有患者获得“不可再激发”状态，也没有因任何原因（毒性或治疗失败）停用氯氮平治疗。
在当前门诊患者中，对从品牌名氯氮平转换为加拿大市场上首个通用替代产品的情况进行回顾性评估，未发现任何显著的治疗变化。
